# Official Journal C 28/2009

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 28 |
| | |
| English edition | Information and Notices | Volume 524 February 2009 |

ISSN 1725-2423

Official Journal

of the European Union

C 28

English edition

Information and Notices

Volume 524 February 2009

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 028/01 | Communication from the Commission — Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006 | 1 |
| 2009/C 028/02 | Non-opposition to a notified concentration (Case COMP/M.5388 — Diester Industrie/Oleon Group) (
  1
  ) | 5 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 028/01

Communication from the Commission — Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006

1

2009/C 028/02

Non-opposition to a notified concentration (Case COMP/M.5388 — Diester Industrie/Oleon Group) (
  1
  )

1

5

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 028/03 | Interest rate applied by the European Central Bank to its main refinancing operations: 2,00 % on 1 February 2009 — Euro exchange rates | 6 |
| 2009/C 028/04 | Administrative Commission on social security for migrant workers | 7 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 028/03

Interest rate applied by the European Central Bank to its main refinancing operations: 2,00 % on 1 February 2009 — Euro exchange rates

6

2009/C 028/04

Administrative Commission on social security for migrant workers

7

| | V   Announcements |
| --- | --- |
| | ADMINISTRATIVE PROCEDURES |
| | European Personnel Selection Office (EPSO) |
| 2009/C 028/05 | Notice of open competitions | 11 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2009/C 028/06 | Prior notification of a concentration (Case COMP/M.5453 — OEP/CCH) — Candidate case for simplified procedure (
  1
  ) | 12 |
| 2009/C 028/07 | Prior notification of a concentration (Case COMP/M.5289 — Agusta/CAE/Rotorsim) — Candidate case for simplified procedure (
  1
  ) | 13 |

V   Announcements

ADMINISTRATIVE PROCEDURES

European Personnel Selection Office (EPSO)

2009/C 028/05

Notice of open competitions

11

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2009/C 028/06

Prior notification of a concentration (Case COMP/M.5453 — OEP/CCH) — Candidate case for simplified procedure (
  1
  )

1

12

2009/C 028/07

Prior notification of a concentration (Case COMP/M.5289 — Agusta/CAE/Rotorsim) — Candidate case for simplified procedure (
  1
  )

1

13

| | |
| --- | --- |
| 2009/C 028/08 | Note to the reader(see page 3 of the cover) | s3 |

2009/C 028/08

Note to the reader(see page 3 of the cover)

Note to the reader

s3

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

---

(1)   Text with EEA relevance

1

| EN | |
| --- | --- |

EN

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 4.2.2009 | EN | Official Journal of the European Union | C 28/1 |
| --- | --- | --- | --- |

4.2.2009

EN

Official Journal of the European Union

C 28/1

---

Communication from the Commission — Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006

(2009/C 28/01)

1.   INTRODUCTION AND SCOPE

Regulation (EC) No 1901/2006 on medicinal products for paediatric use (1) (hereafter the ‘Paediatric’ Regulation) entered into force on 26 January 2007. Article 41(3) of the Regulation requires the Commission to draw up guidance on the nature of the information on paediatric clinical trials to be entered into the database of clinical trials (EudraCT (2)), on which information shall be made available to the public, on how clinical trials results shall be submitted and be made public and on the European Medicines Agency (EMEA)'s responsibilities and tasks in this regard.

This obligation aims to increase the availability of information on the use of medicinal products in the paediatric population and to avoid unnecessary repetition of studies. The information is aimed at the public which includes lay persons, patients and families, health professionals, researchers and academics as well as industry and regulators.

This guidance sets out the nature of the information to be entered into EudraCT, the information to be made accessible to the public, the paediatric clinical trial results to be submitted and made public and on the responsibilities of the EMEA and related tasks in this context.

The information referred to in this guidance comprises paediatric clinical trial protocol-related information and paediatric trial results. Such information is to be entered into EudraCT in cases where the respective paediatric trial has at least one investigator site in the European Economic Area (EEA), and/or is part of an agreed Paediatric Investigation Plan (PIP (3)). It concerns paediatric trials planned, ongoing or completed in the EEA and those that are planned, ongoing or completed in any other country (‘third countries’) provided these latter trials are included in a PIP. The status of each paediatric trial will be identified (e.g. under assessment, authorised or refused, ongoing, prematurely ended or completed). This status will be listed for each Member State.

The EudraCT data fields are for the most part consistent with international initiatives relating to clinical trial registries, e.g. WHO International Clinical Trials Registry Platform (ICTRP) and the International Committee of Medical Journal Editors (ICMJE). Although EudraCT may have additional fields, the convergence of the information to be made public with the WHO ICTRP facilitates the work of sponsors and researchers submitting information to different registries for different purposes, and facilitates access to this information.

The Commission's Directorate-General for Enterprise and Industry (DG ENTR) (4) will make available the list of the specific data fields to be included in EudraCT, and those to be made public.

2.   NATURE OF THE INFORMATION TO BE ENTERED INTO EUDRACT AND TIMING

2.1.   Nature of the information

The nature of the required information to be entered into EudraCT is based on its importance to clinical trials contained in an agreed PIP. Two sets of information are required:

| — | paediatric trial protocol related information — supplied prior to the start of the trial and updated if needed during the trial describing the trial protocol, investigational medicinal products (IMPs), therapeutic indication, trial population, the trial authorisation and the current status of the trial, |
| --- | --- |

—

paediatric trial protocol related information — supplied prior to the start of the trial and updated if needed during the trial describing the trial protocol, investigational medicinal products (IMPs), therapeutic indication, trial population, the trial authorisation and the current status of the trial,

| — | paediatric trial results related information — supplied after the completion of the trial and containing a summary of the results and conclusions. |
| --- | --- |

—

paediatric trial results related information — supplied after the completion of the trial and containing a summary of the results and conclusions.

2.2.   Timing of entering of the information into EudraCT

2.2.1.   Protocol related information

All interventional paediatric clinical trials with at least one site in the EEA are required to be entered into EudraCT no later than at the time of the valid application for authorisation of a clinical trial to the National Competent Authorities (NCA).

All clinical trials that are included in an agreed PIP should also be included, whether the trials are planned, ongoing, or completed.

In particular, all paediatric trials conducted with at least one site in a third country and included in an agreed PIP, should be entered into EudraCT no later than one month after, either, the EMEA decision agreeing a PIP, or, the first approval/positive opinion of the trial by a third country competent authority and/or third country ethics committee, whichever is the latest.

2.2.2.   Result related information

Result-related information for paediatric trials should be submitted to the EMEA, for entry into EudraCT, no more than six months after the trial has ended, whether the trial has been completed or prematurely terminated, whichever occurs first.

However, notwithstanding the above, if

| — | the clinical trial does not fall within the scope of Article 46(1) of the Paediatric Regulation, and |
| --- | --- |

—

the clinical trial does not fall within the scope of Article 46(1) of the Paediatric Regulation, and

| — | it is for objective scientific reasons not possible to submit the result-related information within six months, which has been demonstrated by the submitting party, |
| --- | --- |

—

it is for objective scientific reasons not possible to submit the result-related information within six months, which has been demonstrated by the submitting party,

result-related information for paediatric trials may be submitted to the EMEA, for entry into EudraCT, at the latest within twelve months after the trial has ended, whether the trial has been completed or prematurely terminated, whichever occurs first.

For the purpose of submitting result-related information, a trial is considered completed when the last visit of the last patient has occurred, as foreseen in the latest version of the protocol. This means that, for the purpose of submitting result-related information for inclusion into EudraCT, open trial extensions, e.g. for maintenance treatment, are not considered as part of the trial.

2.2.3.   Submission of the information into EudraCT

The sponsor, PIP holder or Marketing Authorisation Holder (MAH) submits the information electronically to the EudraCT staging area, once such a staging area is operational.

In the interim, the information is submitted in electronic format.

3.   INFORMATION TO BE MADE AVAILABLE TO THE PUBLIC

3.1.   Protocol related information

The information to be included in EudraCT and to be made public will include details of the following elements:

| — | identification of the clinical trial and its protocol, |
| --- | --- |

—

identification of the clinical trial and its protocol,

| — | sponsor, |
| --- | --- |

—

sponsor,

| — | source of funding, |
| --- | --- |

—

source of funding,

| — | contact point for public use, |
| --- | --- |

—

contact point for public use,

| — | identification and description of the treatment arms of the study (IMPs) to be used, |
| --- | --- |

—

identification and description of the treatment arms of the study (IMPs) to be used,

| — | therapeutic objective of the trial (disease under investigation), |
| --- | --- |

—

therapeutic objective of the trial (disease under investigation),

| — | major objectives and endpoints, |
| --- | --- |

—

major objectives and endpoints,

| — | trial design including the countries in which it is to be conducted, |
| --- | --- |

—

trial design including the countries in which it is to be conducted,

| — | trial population, |
| --- | --- |

—

trial population,

| — | inclusion/exclusion criteria, |
| --- | --- |

—

inclusion/exclusion criteria,

| — | trial status (per country or region as applicable), and if refused for ethical reasons the reasons for refusal. |
| --- | --- |

—

trial status (per country or region as applicable), and if refused for ethical reasons the reasons for refusal.

3.2.   Results related information

The information to be included in EudraCT and to be made public should take into account the format for summary of results set out in the ICE E3 guideline (5). It will cover the following elements:

| — | administrative information and trial identification, |
| --- | --- |

—

administrative information and trial identification,

| — | trial design, |
| --- | --- |

—

trial design,

| — | scientific background and explanation of rationale for the trial, |
| --- | --- |

—

scientific background and explanation of rationale for the trial,

| — | participants in the trial — information on the subject population including inclusion exclusion criteria and demographic information, |
| --- | --- |

—

participants in the trial — information on the subject population including inclusion exclusion criteria and demographic information,

| — | interventions — the treatments used, |
| --- | --- |

—

interventions — the treatments used,

| — | objective(s) of the trial, |
| --- | --- |

—

objective(s) of the trial,

| — | outcome measures, |
| --- | --- |

—

outcome measures,

| — | randomisation implementation, |
| --- | --- |

—

randomisation implementation,

| — | blinding, |
| --- | --- |

—

blinding,

| — | statistical methods, |
| --- | --- |

—

statistical methods,

| — | patient disposition, |
| --- | --- |

—

patient disposition,

| — | protocol deviations, |
| --- | --- |

—

protocol deviations,

| — | recruitment, |
| --- | --- |

—

recruitment,

| — | baseline data, |
| --- | --- |

—

baseline data,

| — | trial interruption, |
| --- | --- |

—

trial interruption,

| — | outcomes and estimation, |
| --- | --- |

—

outcomes and estimation,

| — | ancillary analysis, |
| --- | --- |

—

ancillary analysis,

| — | adverse events, |
| --- | --- |

—

adverse events,

| — | trial termination, |
| --- | --- |

—

trial termination,

| — | discussion and interpretation of study results (interpretation of trial results by sponsor, if available and by competent authority, if available), |
| --- | --- |

—

discussion and interpretation of study results (interpretation of trial results by sponsor, if available and by competent authority, if available),

| — | a declaration of the submitting party on liability for the accuracy of the submitted information. |
| --- | --- |

—

a declaration of the submitting party on liability for the accuracy of the submitted information.

3.3.   Timing of making information accessible to the public

Protocol-related information will be made public automatically, once the data has been entered into EudraCT and the trial bas been approved by the NCA concerned. Where a negative opinion bas been issued by an Ethics Committee, the information on the trial will still be published, together with a field indicating the reason for the negative opinion.

Public release of result-related information takes places automatically once this information has been included by the EMEA in the EudraCT database.

3.4.   How information is made public

The information will be made available through a dedicated public website containing a subset of information regularly updated from EudraCT. Appropriate disclaimers will be included to reflect the stage of regulatory evaluation of the trial.

Studies not registered in EudraCT and for which protocol-related information is not available, e.g. because the conduct of the studies predated requirements for inclusion in EudraCT, should be specifically identified.

Result-related information is not validated prior to its inclusion into EudraCT. Responsibility for the result-related information lies with the sponsor, PIP holder or MAH submitting the results.

EudraCT will contain a disclaimer to this effect.

If and when the results are submitted for assessment (e.g. in a marketing authorisation application), a link to the public assessment report will be made.

4.   RESPONSIBILITIES OF THE EMEA AND TASKS IN THIS REGARD

4.1.   The EMEA's responsibilities

The EMEA should:

| — | make public the protocol-related information on paediatric clinical trials in accordance with this guideline and the lists of data fields made public by DG ENTR, |
| --- | --- |

—

make public the protocol-related information on paediatric clinical trials in accordance with this guideline and the lists of data fields made public by DG ENTR,

| — | make public the result-related information on trials included in EudraCT and on any paediatric studies submitted according to Article 45 and 46 of the Paediatric Regulation, |
| --- | --- |

—

make public the result-related information on trials included in EudraCT and on any paediatric studies submitted according to Article 45 and 46 of the Paediatric Regulation,

| — | coordinate the exchange of information, |
| --- | --- |

—

coordinate the exchange of information,

| — | manage the EudraCT database. |
| --- | --- |

—

manage the EudraCT database.

4.2.   The related tasks

The responsibility for the initiation of the process, electronic submission of protocol and result related data, and maintenance of data lies with:

| — | the MAH, in the case of provision of the results of an authorised medicinal product in accordance with the obligations in Articles 45 and 46 of the Paediatric Regulation, |
| --- | --- |

—

the MAH, in the case of provision of the results of an authorised medicinal product in accordance with the obligations in Articles 45 and 46 of the Paediatric Regulation,

| — | the sponsor of trials referred to by Article 41, whether or not it is the MAH, |
| --- | --- |

—

the sponsor of trials referred to by Article 41, whether or not it is the MAH,

| — | the PIP addressee. |
| --- | --- |

—

the PIP addressee.

The EMEA should:

| — | enter into EudraCT the protocol information received electronically for third-country trials including their authorisation status and information regarding the end of trial status, |
| --- | --- |

—

enter into EudraCT the protocol information received electronically for third-country trials including their authorisation status and information regarding the end of trial status,

| — | enter the result information received electronically into EudraCT, |
| --- | --- |

—

enter the result information received electronically into EudraCT,

| — | make public data from the protocol-related and result-related information in accordance with Section 3.4. |
| --- | --- |

—

make public data from the protocol-related and result-related information in accordance with Section 3.4.

The NCAs should:

| — | enter the protocol information received electronically into EudraCT, |
| --- | --- |

—

enter the protocol information received electronically into EudraCT,

| — | enter information concerning the review and oversight of the paediatric trial, |
| --- | --- |

—

enter information concerning the review and oversight of the paediatric trial,

| — | exchange information with the EMEA on the studies submitted, |
| --- | --- |

—

exchange information with the EMEA on the studies submitted,

| — | enter additional data relating to the review and authorisation, amendment and end of the trial, to be recorded directly into EudraCT by the NCAs or by transmission of the information from national clinical trial databases. |
| --- | --- |

—

enter additional data relating to the review and authorisation, amendment and end of the trial, to be recorded directly into EudraCT by the NCAs or by transmission of the information from national clinical trial databases.

5.   IMPLEMENTATION

The guidance set out in this Communication applies:

| — | as regards the protocol-related information, as soon as the programming of EudraCT has been finalised, |
| --- | --- |

—

as regards the protocol-related information, as soon as the programming of EudraCT has been finalised,

| — | as regards the result-related information, once the detailed guidelines for the reporting format have been published and the related programming has been finalised. |
| --- | --- |

—

as regards the result-related information, once the detailed guidelines for the reporting format have been published and the related programming has been finalised.

Finalisation of the programming will be publicly announced.

---

(1)  OJ L 378, 27.12.2006, p. 1.

(2)  http://eudract.emea.europa.eu/

(3)  See point 2, Article 2 of the Paediatric Regulation.

(4)  http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm

(5)  http://www.ich.org/

---

| 4.2.2009 | EN | Official Journal of the European Union | C 28/5 |
| --- | --- | --- | --- |

4.2.2009

EN

Official Journal of the European Union

C 28/5

---

Non-opposition to a notified concentration

(Case COMP/M.5388 — Diester Industrie/Oleon Group)

(Text with EEA relevance)

(2009/C 28/02)

On 8 January 2009, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in French and will be made public after it is cleared of any business secrets it may contain. It will be available:

| — | from the Europa competition website (http://ec.europa.eu/comm/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
| --- | --- |

—

from the Europa competition website (http://ec.europa.eu/comm/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,

| — | in electronic form on the EUR-Lex website under document number 32009M5388. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu). |
| --- | --- |

—

in electronic form on the EUR-Lex website under document number 32009M5388. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 4.2.2009 | EN | Official Journal of the European Union | C 28/6 |
| --- | --- | --- | --- |

4.2.2009

EN

Official Journal of the European Union

C 28/6

---

Interest rate applied by the European Central Bank to its main refinancing operations (1):

2,00 % on 1 February 2009

Euro exchange rates (2)

3 February 2009

(2009/C 28/03)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2849 |
| JPY | Japanese yen | 115,02 |
| DKK | Danish krone | 7,453 |
| GBP | Pound sterling | 0,9029 |
| SEK | Swedish krona | 10,7506 |
| CHF | Swiss franc | 1,4898 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 9,039 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 28,398 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 299,25 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7014 |
| PLN | Polish zloty | 4,5495 |
| RON | Romanian leu | 4,3065 |
| TRY | Turkish lira | 2,1138 |
| AUD | Australian dollar | 2,0113 |
| CAD | Canadian dollar | 1,6058 |
| HKD | Hong Kong dollar | 9,9629 |
| NZD | New Zealand dollar | 2,5418 |
| SGD | Singapore dollar | 1,9456 |
| KRW | South Korean won | 1 785,41 |
| ZAR | South African rand | 13,0019 |
| CNY | Chinese yuan renminbi | 8,7891 |
| HRK | Croatian kuna | 7,4047 |
| IDR | Indonesian rupiah | 15 001,21 |
| MYR | Malaysian ringgit | 4,6507 |
| PHP | Philippine peso | 61,22 |
| RUB | Russian rouble | 46,5075 |
| THB | Thai baht | 44,927 |
| BRL | Brazilian real | 2,9841 |
| MXN | Mexican peso | 18,6413 |
| INR | Indian rupee | 62,189 |

Currency

Exchange rate

USD

US dollar

1,2849

JPY

Japanese yen

115,02

DKK

Danish krone

7,453

GBP

Pound sterling

0,9029

SEK

Swedish krona

10,7506

CHF

Swiss franc

1,4898

ISK

Iceland króna

NOK

Norwegian krone

9,039

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

28,398

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

299,25

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7014

PLN

Polish zloty

4,5495

RON

Romanian leu

4,3065

TRY

Turkish lira

2,1138

AUD

Australian dollar

2,0113

CAD

Canadian dollar

1,6058

HKD

Hong Kong dollar

9,9629

NZD

New Zealand dollar

2,5418

SGD

Singapore dollar

1,9456

KRW

South Korean won

1 785,41

ZAR

South African rand

13,0019

CNY

Chinese yuan renminbi

8,7891

HRK

Croatian kuna

7,4047

IDR

Indonesian rupiah

15 001,21

MYR

Malaysian ringgit

4,6507

PHP

Philippine peso

61,22

RUB

Russian rouble

46,5075

THB

Thai baht

44,927

BRL

Brazilian real

2,9841

MXN

Mexican peso

18,6413

INR

Indian rupee

62,189

---

(1)

Rate applied to the most recent operation carried out before the indicated day. In the case of a variable rate tender, the interest rate is the marginal rate.

(2)  Source: reference exchange rate published by the ECB.

---

| 4.2.2009 | EN | Official Journal of the European Union | C 28/7 |
| --- | --- | --- | --- |

4.2.2009

EN

Official Journal of the European Union

C 28/7

---

ADMINISTRATIVE COMMISSION ON SOCIAL SECURITY FOR MIGRANT WORKERS

(2009/C 28/04)

The annual average costs do not take into account the reduction of 20 % provided for in Articles 94(2) and 95(2) of Council Regulation (EEC) No 574/72 (1).

The net monthly average costs have been reduced by 20 %.

AVERAGE COSTS OF BENEFITS IN KIND — 2003

I.   Application of Article 94 of Regulation (EEC) No 574/72

The amounts to be refunded with regard to the benefits in kind provided in 2003 to members of the family as referred to in Article 19(2) of Regulation (EEC) No 1408/71 (2) will be determined on the basis of the following average costs:

| | Annual | Net Monthly |
| --- | --- | --- |
| Ireland | EUR 3 331,58 | EUR 222,11 |

Annual

Net Monthly

Ireland

EUR 3 331,58

EUR 222,11

II.   Application of Article 95 of Regulation (EEC) No 574/72

The amounts to be refunded with regard to benefits in kind provided in 2003 under Articles 28 and 28a of Regulation (EEC) No 1408/71 will be determined on the basis of the following average costs (only

  per capita
  from 2002):

| | Annual | Net Monthly |
| --- | --- | --- |
| Ireland | EUR 6 267,00 | EUR 417,80 |

Annual

Net Monthly

Ireland

EUR 6 267,00

EUR 417,80

AVERAGE COSTS OF BENEFITS IN KIND — 2004

I.   Application of Article 94 of Regulation (EEC) No 574/72

The amounts to be refunded with regard to the benefits in kind provided in 2004 to members of the family as referred to in Article 19(2) of Regulation (EEC) No 1408/71 will be determined on the basis of the following average costs:

| | Annual | Net Monthly |
| --- | --- | --- |
| Ireland | EUR 3 527,51 | EUR 235,17 |
| Hungary (per capita)






  — | Workers' family members under 65 |

Annual

Net Monthly

Ireland

EUR 3 527,51

EUR 235,17

Hungary (per capita)

—

Workers' family members under 65

| — | Pensioners under 65 |
| --- | --- |

—

Pensioners under 65

| — | Pensioners' family members under 65 |
| --- | --- |

—

Pensioners' family members under 65

HUF 74 661

HUF 4 977

II.   Application of Article 95 of Regulation (EEC) No 574/72

The amounts to be refunded with regard to benefits in kind provided in 2004 under Articles 28 and 28a of Regulation (EEC) No 1408/71 will be determined on the basis of the following average costs (only

  per capita
  from 2002):

| | Annual | Net Monthly |
| --- | --- | --- |
| Ireland | EUR 6 789,44 | EUR 452,63 |
| Hungary







  — | Workers' family members aged 65 and over |

Annual

Net Monthly

Ireland

EUR 6 789,44

EUR 452,63

Hungary

—

Workers' family members aged 65 and over

| — | Pensioners aged 65 and over |
| --- | --- |

—

Pensioners aged 65 and over

| — | Pensioners' family members aged 65 and over |
| --- | --- |

—

Pensioners' family members aged 65 and over

HUF 223 541

HUF 14 903

AVERAGE COSTS OF BENEFITS IN KIND — 2005

I.   Application of Article 94 of Regulation (EEC) No 574/72

The amounts to be refunded with regard to the benefits in kind provided in 2005 to members of the family as referred to in Article 19(2) of Regulation (EEC) No 1408/71 will be determined on the basis of the following average costs:

| | Annual | Net Monthly |
| --- | --- | --- |
| Cyprus | EUR 602,05 | EUR 40,14 |
| Hungary (per capita)






  — | Workers' family members under 65 |

Annual

Net Monthly

Cyprus

EUR 602,05

EUR 40,14

Hungary (per capita)

—

Workers' family members under 65

| — | Pensioners under 65 |
| --- | --- |

—

Pensioners under 65

| — | Pensioners' family members under 65 |
| --- | --- |

—

Pensioners' family members under 65

HUF 81 790

HUF 5 453

Poland (per capita)

| — | Workers' family members under 65 |
| --- | --- |

—

Workers' family members under 65

| — | Pensioners under 65 |
| --- | --- |

—

Pensioners under 65

| — | Pensioners' family members under 65 |
| --- | --- |

—

Pensioners' family members under 65

PLN 709,36

PLN 47,29

II.   Application of Article 95 of Regulation (EEC) No 574/72

The amounts to be refunded with regard to benefits in kind provided in 2005 under Articles 28 and 28a of Regulation (EEC) No 1408/71 will be determined on the basis of the following average costs (only

  per capita
  from 2002):

| | Annual | Net Monthly |
| --- | --- | --- |
| Cyprus | EUR 816,63 | EUR 54,44 |
| Hungary







  — | Workers' family members aged 65 and over |

Annual

Net Monthly

Cyprus

EUR 816,63

EUR 54,44

Hungary

—

Workers' family members aged 65 and over

| — | Pensioners aged 65 and over |
| --- | --- |

—

Pensioners aged 65 and over

| — | Pensioners' family members aged 65 and over |
| --- | --- |

—

Pensioners' family members aged 65 and over

HUF 250 427

HUF 16 695

Poland

| — | Workers' family members aged 65 and over |
| --- | --- |

—

Workers' family members aged 65 and over

| — | Pensioners aged 65 and over |
| --- | --- |

—

Pensioners aged 65 and over

| — | Pensioners' family members aged 65 and over |
| --- | --- |

—

Pensioners' family members aged 65 and over

PLN 2 203,05

PLN 146,87

AVERAGE COSTS OF BENEFITS IN KIND — 2006

I.   Application of Article 94 of Regulation (EEC) No 574/72

The amounts to be refunded with regard to the benefits in kind provided in 2006 to members of the family as referred to in Article 19(2) of Regulation (EEC) No 1408/71 will be determined on the basis of the following average costs:

| | Annual | Net Monthly |
| --- | --- | --- |
| Belgium | EUR 1 376,48 | EUR 91,77 |
| France | EUR 2 084,19 | EUR 138,95 |
| Portugal | EUR 977,88 | EUR 65,19 |

Annual

Net Monthly

Belgium

EUR 1 376,48

EUR 91,77

France

EUR 2 084,19

EUR 138,95

Portugal

EUR 977,88

EUR 65,19

II.   Application of Article 95 of Regulation (EEC) No 574/72

The amounts to be refunded with regard to benefits in kind provided in 2006 under Articles 28 and 28a of Regulation (EEC) No 1408/71 will be determined on the basis of the following average costs (only

  per capita
  from 2002):

| | Annual | Net Monthly |
| --- | --- | --- |
| Belgium | EUR 4 514,79 | EUR 300,99 |
| France | EUR 4 907,18 | EUR 327,15 |
| Portugal | EUR 1 779,86 | EUR 118,66 |

Annual

Net Monthly

Belgium

EUR 4 514,79

EUR 300,99

France

EUR 4 907,18

EUR 327,15

Portugal

EUR 1 779,86

EUR 118,66

AVERAGE COSTS OF BENEFITS IN KIND — 2007

I.   Application of Article 94 of Regulation (EEC) No 574/72

The amounts to be refunded with regard to the benefits in kind provided in 2007 to members of the family as referred to in Article 19(2) of Regulation (EEC) No 1408/71 will be determined on the basis of the following average costs:

| | Annual | Net Monthly |
| --- | --- | --- |
| The Czech Republic (per capita)






  — | Workers' family members under 65 |

Annual

Net Monthly

The Czech Republic (per capita)

—

Workers' family members under 65

| — | Pensioners under 65 |
| --- | --- |

—

Pensioners under 65

| — | Pensioners' family members under 65 |
| --- | --- |

—

Pensioners' family members under 65

CZK 13 246,34

CZK 883,09

Spain

EUR 1 187,84

EUR 79,19

Latvia

LVL 255,01

LVL 17,00

Lithuania (per capita)

| — | Workers' family members under 65 |
| --- | --- |

—

Workers' family members under 65

| — | Pensioners under 65 |
| --- | --- |

—

Pensioners under 65

| — | Pensioners' family members under 65 |
| --- | --- |

—

Pensioners' family members under 65

LTL 838,90

LTL 55,93

Slovenia (per capita — per family member of a worker)

EUR 592,41

EUR 39,49

Liechtenstein

CHF 4 276,34

CHF 285,09

Norway

NOK 39 303

NOK 2 620

Switzerland

CHF 2 581,87

CHF 172,12

II.   Application of Article 95 of Regulation (EEC) No 574/72

The amounts to be refunded with regard to benefits in kind provided in 2007 under Articles 28 and 28a of Regulation (EEC) No 1408/71 will be determined on the basis of the following average costs (only

  per capita
  from 2002):

| | Annual | Net Monthly |
| --- | --- | --- |
| The Czech Republic







  — | Workers' family members aged 65 and over |

Annual

Net Monthly

The Czech Republic

—

Workers' family members aged 65 and over

| — | Pensioners aged 65 and over |
| --- | --- |

—

Pensioners aged 65 and over

| — | Pensioners' family members aged 65 and over |
| --- | --- |

—

Pensioners' family members aged 65 and over

CZK 40 758,70

CZK 2 717,25

Spain

EUR 3 242,51

EUR 216,17

Latvia

LVL 320,07

LVL 21,34

Lithuania

| — | Workers' family members aged 65 and over |
| --- | --- |

—

Workers' family members aged 65 and over

| — | Pensioners aged 65 and over |
| --- | --- |

—

Pensioners aged 65 and over

| — | Pensioners' family members aged 65 and over |
| --- | --- |

—

Pensioners' family members aged 65 and over

LTL 2 241,18

LTL 149,41

Slovenia

EUR 1 559,55

EUR 103,97

Liechtenstein

CHF 8 459,40

CHF 563,96

Norway

NOK 74 640

NOK 4 976

Switzerland

CHF 6 836,65

CHF 455,78

---

(1)  OJ L 74, 27.3.1972, p. 1.

(2)  OJ L 149, 5.7.1971, p. 2.

---

V Announcements

ADMINISTRATIVE PROCEDURES

European Personnel Selection Office (EPSO)

| 4.2.2009 | EN | Official Journal of the European Union | C 28/11 |
| --- | --- | --- | --- |

4.2.2009

EN

Official Journal of the European Union

C 28/11

---

NOTICE OF OPEN COMPETITIONS

(2009/C 28/05)

The European Personnel Selection Office (EPSO) is organising the following open competitions:

| — | — | EPSO/AST/77/09 | — | Assistants (AST 1) with Cypriot citizenship (CY) |
| --- | --- | --- | --- | --- |
| — | — | EPSO/AST/78/09 | — | Assistants (AST 1) with Czech citizenship (CZ) |
| — | — | EPSO/AST/79/09 | — | Assistants (AST 1) with Estonian citizenship (EE) |
| — | — | EPSO/AST/80/09 | — | Assistants (AST 1) with Hungarian citizenship (HU) |
| — | — | EPSO/AST/81/09 | — | Assistants (AST 1) with Lithuanian citizenship (LT) |
| — | — | EPSO/AST/82/09 | — | Assistants (AST 1) with Latvian citizenship (LV) |
| — | — | EPSO/AST/83/09 | — | Assistants (AST 1) with Maltese citizenship (MT) |
| — | — | EPSO/AST/84/09 | — | Assistants (AST 1) with Polish citizenship (PL) |
| — | — | EPSO/AST/85/09 | — | Assistants (AST 1) with Slovenian citizenship (SI) |
| — | — | EPSO/AST/86/09 | — | Assistants (AST 1) with Slovak citizenship (SK) |

—

—

EPSO/AST/77/09

—

Assistants (AST 1) with Cypriot citizenship (CY)

—

—

EPSO/AST/78/09

—

Assistants (AST 1) with Czech citizenship (CZ)

—

—

EPSO/AST/79/09

—

Assistants (AST 1) with Estonian citizenship (EE)

—

—

EPSO/AST/80/09

—

Assistants (AST 1) with Hungarian citizenship (HU)

—

—

EPSO/AST/81/09

—

Assistants (AST 1) with Lithuanian citizenship (LT)

—

—

EPSO/AST/82/09

—

Assistants (AST 1) with Latvian citizenship (LV)

—

—

EPSO/AST/83/09

—

Assistants (AST 1) with Maltese citizenship (MT)

—

—

EPSO/AST/84/09

—

Assistants (AST 1) with Polish citizenship (PL)

—

—

EPSO/AST/85/09

—

Assistants (AST 1) with Slovenian citizenship (SI)

—

—

EPSO/AST/86/09

—

Assistants (AST 1) with Slovak citizenship (SK)

in the secretarial field.

The competition notices are published in Official Journal C 28 A of 4 February 2009 in English, French and German only.

Further details can be found on the EPSO website: http://europa.eu/epso

---

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 4.2.2009 | EN | Official Journal of the European Union | C 28/12 |
| --- | --- | --- | --- |

4.2.2009

EN

Official Journal of the European Union

C 28/12

---

Prior notification of a concentration

(Case COMP/M.5453 — OEP/CCH)

Candidate case for simplified procedure

(Text with EEA relevance)

(2009/C 28/06)

| 1. | On 26 January 2009, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking One Equity Partners II L.P. (‘OEP’, USA), controlled by JPMorgan Chase & Co (USA) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of the undertaking Columbian Chemicals Holding LLC (‘CCH’, USA) by way of purchase of shares. |
| --- | --- |

1.

On 26 January 2009, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking One Equity Partners II L.P. (‘OEP’, USA), controlled by JPMorgan Chase & Co (USA) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of the undertaking Columbian Chemicals Holding LLC (‘CCH’, USA) by way of purchase of shares.

| 2. | The business activities of the undertakings concerned are:






  — | for undertaking OEP: private equity fund, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for undertaking OEP: private equity fund,

| — | for undertaking CCH: production and sales of carbon black. |
| --- | --- |

—

for undertaking CCH: production and sales of carbon black.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5453 — OEP/CCH, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Brussels |

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5453 — OEP/CCH, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Brussels

---

(1)  OJ L 24, 29.1.2004, p. 1.

(2)  OJ C 56, 5.3.2005, p. 32.

---

| 4.2.2009 | EN | Official Journal of the European Union | C 28/13 |
| --- | --- | --- | --- |

4.2.2009

EN

Official Journal of the European Union

C 28/13

---

Prior notification of a concentration

(Case COMP/M.5289 — Agusta/CAE/Rotorsim)

Candidate case for simplified procedure

(Text with EEA relevance)

(2009/C 28/07)

| 1. | On 26 January 2009, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings Agusta S.p.A. (‘Agusta’, Italy), controlled by Finmeccanica — Societa per Azioni (Italy), and CAE Aviation Training B.V. (‘CAE’, The Netherlands), belonging to CAE Inc. (Canada) acquire within the meaning of Article 3(1)(b) of the Council Regulation, joint control over Rotorsim Srl. (‘Rotorsim’, Italy) by way of purchase of shares in a newly created company constituting a joint venture. |
| --- | --- |

1.

On 26 January 2009, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings Agusta S.p.A. (‘Agusta’, Italy), controlled by Finmeccanica — Societa per Azioni (Italy), and CAE Aviation Training B.V. (‘CAE’, The Netherlands), belonging to CAE Inc. (Canada) acquire within the meaning of Article 3(1)(b) of the Council Regulation, joint control over Rotorsim Srl. (‘Rotorsim’, Italy) by way of purchase of shares in a newly created company constituting a joint venture.

| 2. | The business activities of the undertakings concerned are:






  — | for Agusta: manufacturing of helicopters and provision of related services, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Agusta: manufacturing of helicopters and provision of related services,

| — | for CAE: provision of simulation and control technologies and training solutions for aerospace, |
| --- | --- |

—

for CAE: provision of simulation and control technologies and training solutions for aerospace,

| — | for Rotorsim: operation of flight simulators. |
| --- | --- |

—

for Rotorsim: operation of flight simulators.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5289 — Agusta/CAE/Rotorsim, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Brussels |

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5289 — Agusta/CAE/Rotorsim, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Brussels

---

(1)  OJ L 24, 29.1.2004, p. 1.

(2)  OJ C 56, 5.3.2005, p. 32.

---

4.2.2009

| 4.2.2009 | EN | Official Journal of the European Union | C 28/s3 |
| --- | --- | --- | --- |

EN

Official Journal of the European Union

C 28/s3

---

NOTE TO THE READER

The institutions have decided no longer to quote in their texts the last amendment to cited acts.

Unless otherwise indicated, references to acts in the texts published here are to the version of those acts currently in force.

---